Kornimate/medical-research-clean huggingface dataset:
serum sphingolipidomic analyses in healthy, diabetic and prediabetic subjects

Conditions: Diabetes Mellitus, Type 2; Prediabetic State

Summary: this study is designed to compare the serum sphingolipidomic analyses in healthy, pre-diabetic and diabetic subjects. age, sex and bmi are matched among these three groups. as ceramide, sphingosine, sphingosine-1-phosphate and sphinganine are involved in inflammation, immunity and cancer, investigators proposed a hypothesis that sphingosine-1-phosphate and other sphingolipids may be associated with the progress of type 2 diabetes. sphingolipids may be a biomarker for diabetes.

the first purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the weight among type 2 diabetes. 60 patients with diagnosed type 2 diabetes will be recruited. the serum concentrations of sphingolipid metabolites of 20 type 2 diabetic patients with obesity will be compared to age- and sex-matched series of 40 type 2 patients without obesity. the second purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the process and severity of type 2 diabetes. the serum concentrations of sphingolipid metabolites of 20 subjects with type 2 diabetes will be compared to age-, sex- and bmi-matched series of healthy and pre-diabetic subjects. investigators speculate that the serum concentration of sphingolipid metabolites are positively related with the progression of diabetes. in order to discover why serum sphingolipid metabolites correlates with the progression of diabetes, detailed information on hba1c, duration of diabetes history and insulin resistance defined by homeostatic model assessment (homa-ir) will be analysed. these three parameters may affect the serum concentrations of sphingolipid metabolites.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus, type 2 * clinical diagnosis of prediabetic status * older than 18 and younger than 90 years-old * clinical diagnosis of insulin-resistance * clinical diagnosis of newly onset of diabetes mellitus, type 2 * those who are willing to participate in the trial and sign the consent form exclusion criteria: * any cardiovascular disease (myocardial infarction, heart failure, cerebrovascular accident) * missing information of bmi * sever liver, kidney dysfunction * sever pancreatitis or those who received pancreatectomy * on medications of hormone, immunosuppressive therapy or drugs that may affect the bioactivity or concentration of sphingolipids (e.g. asprin ) * patients on pregnancy * sever systematic diseases including carcinoma, mental disorder, sever anemia et al.

Keywords: sphingolipid diabetes mellitus biomarker obesity insulin resistance
safety and efficacy of zylet vs lotemax, tobramycin and vehicle in pediatric blepharoconjunctivitis

Conditions: Conjunctivitis

Summary: the objective of this study is to evaluate the safety and effectiveness of zylet in comparison with lotemax, tobramycin and the vehicle of zylet for the treatment of blepharoconjunctivitis in pediatric subjects.


Eligibility criteria:
inclusion criteria: * children 0-6 years of age. * clinical diagnosis of blepharoconjunctivitis * parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures. * parent/guardian must understand, be willing and able to provide informed consent and health insurance portability accountability act (hipaa) authorization. exclusion criteria: * known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication. * subjects who have a history of ocular surgery, including laser procedures, within the past 6 months. * subjects who are monocular. * subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study. * subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Keywords: blepharokeratoconjunctivitis
heart rate variability (hrv) biofeedback to treat ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a prospective interventional study exploring the modifiability of physiological metrics, namely heart rate variability (hrv), using a 5-week standardized hrv biofeedback intervention in subjects with symptomatic ulcerative colitis. participants will be followed for 17 weeks. the goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.


Eligibility criteria:
inclusion criteria: * adult subjects (18-65 years old) * ulcerative colitis with a symptomatic flare (sccai ≥3) and without inflammation (fc\<250µg/ml) exclusion criteria: * individuals who take medications known to alter heart rate variability * individuals with pacemakers or other implantable devices
a cumulative dose study to evaluate the safety and efficacy of albuterol in a dry powder inhaler and an hfa mdi (hydrofluoroalkane metered dose inhaler)

Conditions: Asthma

Summary: the study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, albuterol in a dry powder inhaler and albuterol in an hfa (hydrofluoroalkane), metered dose inhaler.

the study objective is to compare the efficacy and safety of albuterol in a dry powder inhaler (dpi) and albuterol in an hfa metered dose inhaler (mdi) after a cumulative dose of 1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). another study objective is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers. the pharmacokinetics of albuterol will be examined in half (24) of the study subjects. to participate in the study, patients must provide written informed consent, washout any prohibited medications and pass all the screen criteria. once this is done, there will be two treatment visits. at each visit the subject will inhale with both types of inhalers. at each visit, one inhaler will have active drug (albuterol) and one inhaler will have placebo (dummy). the inhaler with the active drug will be switched at the two visits in a random manner. at each visit the subject will inhale with each inhaler a total of 16 times by a specific schedule. the subject will inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice (2), wait 30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then inhale from each inhaler eight times (8). the total time to complete the inhalations should be about 2 hours. following that, there will be a series of assessments taken at regular times with vital signs measured up to 6 hours, ecg (electrocardiogram) assessed up to 4 hours, blood taken to measure potassium and glucose up to 4 hours, lung function evaluated with spirometry up to 6 hours, and for those subjects participating in the pharmacokinetic evaluation blood will be drawn up to 12 hours. the two study treatment visits will be 3 to 14 days apart. following these visits, there will be a study concluding visit 1 to 5 days later.

Eligibility criteria:
inclusion criteria: * must provide written informed consent, * must be between 18-45 years of age, * male or female, females of non-child bearing potential or using reliable contraception * asthma for at least 6 months, fev1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180mcg albuterol * stable low dose of inhaled corticosteroids * non-smoker * otherwise healthy * other criteria apply exclusion criteria: * pregnant * allergic to albuterol or severe milk protein allergy * only for subject participating in pk assessments, must not have donated blood within 30 days. * other criteria apply

Keywords: asthma dry powder inhaler short-acting beta2-agonist saba bronchoconstriction bronchodilation bronchodilator metered dose inhaler
long-term follow-up study of subjects treated with autologous t cells using the sleeping beauty system to express tcrs

Conditions: Gynecologic Cancer; Colorectal Cancer; Pancreatic Cancer; Non-small Cell Lung Cancer; Cholangiocarcinoma; Ovarian Cancer; Ovary Neoplasm; Squamous Cell Lung Cancer; Adenocarcinoma of Lung; Adenosquamous Cell Lung Cancer

Summary: long-term follow-up study for subjects enrolled in the phase i/ii study of autologous t cells engineered using the sleeping beauty system to express t cell receptors (tcrs) reactive against cancer-specific mutations in subjects with solid tumors

this is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous t cells engineered using the sleeping beauty system to express t cell receptors (tcrs) reactive against cancer-specific mutations (neoantigen specific tcr-t cells). in this study, subjects will be followed for up to 15 years after initial tcr-t cell drug product administration for evaluation of delayed adverse events (aes).

Eligibility criteria:
inclusion criteria: 1. subjects treated with tcr-t cell drug product on study tcr001-201 or any other alaunos tcr-t cell drug product study and have either completed their original treatment protocol or have discontinued early. 2. subject is willing and able to adhere to the study visit schedule and other protocol requirements. 3. subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 4. subjects agree to allow clinical samples to be collected and stored at study site and/or alaunos therapeutics, inc. (alaunos) or designee for testing. exclusion criteria: 1. subjects that were consented to this ltfu study but did not receive tcr-t cell drug product on study tcr001-201 will be excluded. no other exclusions are permitted.
cardiofocus heartlight post-approval study

Conditions: Atrial Fibrillation

Summary: this is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the heartlight system to confirm results of the previously conducted pivotal clinical study.

this is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the heartlight system during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

Eligibility criteria:
inclusion criteria: * 18 years or older * planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation * failure of at least one anti-arrhythmic drug * others exclusion criteria: * overall good health as established by multiple criteria
a field experiment to assess the demand for hiv self-tests in zimbabwe

Conditions: HIV/AIDS

Summary: this study is a field experiment in peri-urban and rural communities near harare, zimbabwe, that seeks to estimate the likelihood that individuals will purchase hiv self-tests under various pricing and distribution strategies. about 4,000 adults will be randomly selected, administered a short questionnaire, and given vouchers that will offer them hiv self-tests at randomly allocated prices and distribution sites. the study will also test whether the provision of hiv self-tests can be targeted more cost-effectively to reach high-risk persons and non- recent testers. last, the study will explore whether demand for repeated hiv self-testing is contingent on the price offered initially.

this study is a field experiment that seeks to obtain "revealed preference" estimates of the likelihood that individuals will purchase oral fluid-based hiv self-tests at alternative prices. such an approach is useful for estimating the price sensitivity (or elasticity) of demand for hiv self-tests. the study will also estimate the extent to which demand for self-tests differs by certain distribution channels such as retail outlets, public sector health facilities, and other community-based venues. importantly, the experiment will also test whether the provision of hiv self-tests can be targeted more cost-effectively to reach high-risk persons and non-recent testers by examining the demand for self-tests in these populations in responses to various prices and distribution strategies. the results of the study will provide vital information required by policy makers and implementers on the optical pricing and distribution strategies for introducing hiv self-tests and scaling up hivst in resource-limited settings. in a subsequent study with additional funding, the study will also seek to determine the long-term implications of offering self-tests at very low prices initially; specifically, it will assess whether free distribution initially suppresses individuals' willingness to pay for self-tests in the future. roughly 12 months after the initial voucher offer, participants who provided a mobile phone number they can access within their household will be contacted via phone-based text messages and offered the same hiv self-tests again at one common non-zero price. the purchases at 12 months will once again be monitored and linked to participants via a unique identifier that is included in the text messages.

Eligibility criteria:
inclusion criteria: * age 16 years or older * willing and able to provide written informed consent for participation * intends to stay in the study area for at least 12 months
school-based behavioural intervention to face obesity and promote cardiovascular health among spanish adolescents

Conditions: Obesity; Cardiovascular Health; Diabetes Mellitus

Summary: background and objective: there is an alarming increase in obesity and unhealthy lifestyles in adolescents. this issue threatens to have a highly negative health and socioeconomic impact in the near future. the only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. the school is the most appropriate environment for such an intervention. the main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. the project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits. methodology: a cluster-randomized controlled trial involving 24 secondary schools in spain will be carried out. schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy x-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. the primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the ideal cardiovascular health score. secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. participants will be measured again when they reach 20 years old. expected results: the investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among spanish adolescents, including obesity/adiposity and metabolic profiles. if successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.


Eligibility criteria:
inclusion criteria: * • any student studying the first academic year of secondary school (enseñanza secundaria obligatoria, eso) in the selected high schools. exclusion criteria: * no exclusion criteria.

Keywords: obesity cardiovascular health diabetes adolescents physical activity diet school-based
evaluation of n6 sound processor in group of freedom users

Conditions: Sensory Hearing Loss

Summary: study of freedom sound processor users that upgrade to n6 sound processor cp900 series. to test speech understanding in each device and usability of upgrade.


Eligibility criteria:
inclusion criteria: * subjects with sensorineural hearing loss * 12 years of age and older * currently using freedom sound processor * recipient of a ci22m or ci24 series implant * minimum of 3 months experience with freedom sound processor * prior documentation of sentence recognition in noise at a +10 snr or better * native english speaker * willingness to participate and comply with requirements of protocol exclusion criteria: * unable to complete test metrics * unrealistic expectations regarding possible benefits * additional handicaps that would prevent or restrict participation in audiological evaluations * abi cochlear implant recipient
fractionated busulfan conditioning regimen for allo-hsct in non-remission myeloid malignancies

Conditions: Myeloid Malignancies

Summary: the goal of this single-arm phase ii study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-hsct). the main question it aims to answer are: * the safety and efficacy of fractionated busulfan combined with chidamide/fludarabine/cytarabine(chifab) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-hsct. * the efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-hsct. participants will receive fractionated busulfan-based chifab conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\~-3, fludarabine 35mg/m2 d-6\~-2, cytarabine 1g/m2,d-6\~-2, chidamide 30mg d-13,-10,-6,-3) before allo-hsct.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old and ≤ 65 years old when signing the informed consent form (icf); 2. kps score \> 60 or ecog score 0-2; 3. the expected survival period \> 3 months; 4. those who did not achieve complete remission after 2 or more chemotherapy regimens. the proportion of blasts on bone marrow smears before transplantation was ≥5%. 5. those who have no central nervous system involvement or serious functional damage to important organs of the body; 6. fully understand and be informed of this study and sign the icf; willing to follow and have the ability to complete all test procedures; exclusion criteria: 1. serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; 2. uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; 3. participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; 4. combined with other malignant tumors and require treatment; 5. pregnant or lactating females; 6. patients with known history of human immunodeficiency virus (hiv) virus infection and/or acquired immunodeficiency syndrome; 7. patients with active chronic hepatitis b or active hepatitis c; 8. history of prolonged qt syndrome; 9. patients considered by other researchers to be unsuitable for this study

Keywords: myeloid malignancies allo-hsct
duration of cardiac antimicrobial prophylaxis outcomes study

Conditions: Surgical Site Infection

Summary: this multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (arm a), to 24 hours (arm b) and, to 48 hours (arm c) of iv cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery

this trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery. calipso, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase iv, noninferiority trial will examine the incidence proportion of ssi following cardiac surgery. our three-intervention trial will compare: arm a administration of prophylaxis in intraoperative period only arm b administration of prophylaxis in intraoperative plus for 24 hours postoperatively arm c administration of prophylaxis in intraoperative plus for 48 hours postoperatively

Eligibility criteria:
inclusion criteria: - adult patients undergoing cardiac surgery involving a median sternotomy exclusion criteria: * age \<18 years * american society of anesthesiology (asa) 5 * subjects with gfr \<40ml/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis * surgery for suspected or proven endocarditis or deep sternal wound infection * documented cefazolin hypersensitivity * documented methicillin resistant staphylococcus aureus (mrsa) colonisation or infection in the 12-months prior to index surgery * cardiac transplantation * procedures involving insertion ventricular assist device or mechanical circulatory support device * procedures not involving a median sternotomy * patients previously enrolled and randomised to the calipso trial

Keywords: cardiac surgery
a randomized, double-blind, placebo-controlled, sequential ascending, single-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of e2212 in healthy subjects

Conditions: Alzheimer's Disease

Summary: this study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) in plasma and cerebrospinal (csf) following single oral doses of e2212.


Eligibility criteria:
inclusion criteria: 1. healthy men and women of non-child bearing potential age 18 and 55 years old at the time of screening; 2. body mass index (bmi) 18 and 30 kg/m2 at screening; 3. are willing and able to comply with all aspects of the protocol; and 4. provide written informed consent. exclusion criteria: 1. clinically important abnormalities on physical examination, vital signs or clinical laboratories. 2. history of serious medical illness 3. smoking or use of tobacco-containing products within past 3 months 4. history of alcohol or drug abuse within past 2 years